Difficulty of breathing while sleeping often manifests itself as snoring or the more serious obstructive sleep apnea. Snoring is a condition affecting approximately 40% of the adult population, while obstructive sleep apnea affects approximately 7% of the adult population. Although snoring can occur as a result of a physical anomaly, such as enlarged tonsils or adenoids, generally, snoring occurs during sleep, because the muscles of the upper throat relax. As a person breathes, the turbulence of the air causes a flutter valve effect on the soft tissues of the upper throat. The vibration resulting from the flutter valve effect of the soft tissues of the upper throat causes snoring sounds.
Sleep apnea is due to the obstruction of the upper airway which produces short episodes of breathing stoppage that characterizes apnea. Frequent arousals during the night occur when the patient awakens in order to overcome the airway blockage. As a result, sleep apnea can cause excessive daytime sleepiness as well as high blood pressure, strokes or cardiac arrest.
Although such severe steps can be taken to alleviate snoring or the more serious condition of sleep apnea as performing a surgery, such as a tracheostomy, to ensure adequate air exchange; it is desirable to provide a treatment that is non-surgical, non-evasive, comfortable, and not unsightly. It is also advantageous to provide a treatment that the patient has prior knowledge of its effectiveness to further ensure compliance.
Currently, there are a number of therapeutic apparatus that do not require surgery. U.S. Pat. Nos. 4,715,368 and Re. 33,442 issued to George discloses an oral device to prevent the closing of the breathing passage. The oral device consists of a one-piece mouthpiece having a front beak housing with an orifice airway therein. The oral device is custom-fitted and anchored to appropriate molars with wire clasps and a guide. A disadvantage of this oral device is that it is obvious to the observer when a patient is wearing the apparatus. If a patient is self-conscious about the oral apparatus he would be disinclined to wear it and thus defeat the purpose. Another disadvantage is that flanges are used to depress and constrain the tongue of the patient to prevent the breathing passage to close. This constraint on the tongue can prove uncomfortable to the patient, and discourage its use.
U.S. Pat. No. 5,092,346 issued to Hayes and Meade discloses a dental device which grips all upper teeth forward of the pre-molars and has a downwardly extending ramp against which the lower teeth engage during sleep. An aperture in the device between the upper portion and the lower portion facilitates the passage of air for mouth breathing and attracts the tongue forward.
U.S. Pat. No. 5,003,994 issued to Cook discloses an oral device which has a rigid shell with appliance socket structure adapted to engage the upright portion of tooth and gum of either the top or bottom jaw. The device also includes a cam structure which extends downwardly and has a pliant tooth contacting material such as silicone to forcibly position the mandible forward. Similar to the Hayes and Meade device, this oral device includes a central breathing aperture.
In both of the devices disclosed in Cook and in Hayes, et al., the oral devices invade the patient's mouth to such a degree that it is obvious to both him and an observer. In order to ensure patient compliance, it is desirable to have an oral device that is both comfortable to wear and aesthetic for viewing by other household members.
Because snoring and sleep apnea may be the result of structural anomalies, such as enlarged tonsils and adenoids, or nasal polyps to name a few, it is necessary to first examine the patient before prescribing an oral device. If a structural anomaly is the cause of the breathing disorder during sleep, then surgery would be the recommended procedure.
If, in fact, the patient is not suffering from a structural anomaly, it is nonetheless necessary to determine whether the oral apparatus will, in fact, alleviate the snoring problem. It is also advantageous to provide a method and device which will assure the patient that the completed apparatus will successfully alleviate snoring before he has incurred the expense of purchasing the oral device. The prior art does not address the need for such testing.